MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. NEUTRON¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	NC100
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in (b)(6) of 2025 involving a neutron¿ where the customer stated that, ¿s: patient received 3 cap changes during a 6-day period.2 cap changes were prematurely done due to possible cap malfunction.B: patient was received blood transfusion on [redacted], a 2nd syringe (aliquot) was administered at 1740 in the purple lumen and came down at 2048.Before disconnecting the blood, the nurse (rn) noticed some blood on the threads of the cap.Rn wiped the outside of the cap with chg swab, but upon closer inspection the inside of the cap had a very small amount of blood.When flushing the line, the fluids flushing did not enter the empty space of the cap, the blood tubing had blood on the threads on the end.The rn believes that when blood was over primed where a small amount on the end somehow entered the cap when it was being connected.The rn kept the cap on patient to do a change with 4am lab draws to minimize entering patient line multiple times.Rn continuously checked on the cap to ensure no changes occurred.On [redacted] at 0352 cap on the purple lumen was changed (was unable to change cap on white lumen because it was infusing tpn/lipids/tacro).This cap was saved and given to unit educator.On [redacted] at 2132 the white lumen cap and line was changed as scheduled and changed the purple lumen cap to align the caps and lines to the same schedule.Reference and lot numbers below recorded in patient chart with cap change.R: i believe the tubing used for blood administration via syringe may have caused the blood to enter the inside of the cap due to over depression of the cap¿s silicone top.It is possible that the blood syringe tubing with the male luer ending/connector might be too long and doesn¿t have a ¿stopper¿ to prevent over inserting the male luer end into the neutron.Neutron cap with blood collected inside septum channel and septum channel stuck in open position after blood transfusions.It occurred multiple times during a 6-day period.The patient was a 2-year-old female.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: NEUTRON¿
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21742463
• Report Number: 9617594-2025-00613
• Device Sequence Number: 20989209
• Product Code: FPA
• UDI-Device Identifier: 00840619065485
• UDI-Public: (01)00840619065485(17)290101(10)13889419
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NC100
• Device Lot Number: 13889419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/01/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIPIDS, MFR UNK.; TACRO (TACROLIMUS), MFR UNK.; TOTAL PARENTERAL NUTRITION (TPN).
• Patient Age: 24 MO
• Patient Sex: Female